Ketamine Add-On Therapy for Established Status Epilepticus Treatment Trial

Investigational Therapy for Persistent Seizures (Status Epilepticus)

P
Paul Musey, MD

Primary Investigator

Enrolling By Invitation
1 years or above
All
Phase N/A
2 participants needed
2 Locations

Brief description of study

The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

KESETT is a multicenter, randomized, blinded study to determine whether adding 1 mg/kg or 3 mg/kg dose of KET to 60 mg/kg LEV can terminate status epilepticus (SE) in a larger fraction of subjects with benzodiazepine-refractory SE than those treated with LEV (60 mg/kg) alone.

The primary outcome is termination of SE from 15 minutes after starting the study drug infusion, sustained until 60 minutes from enrollment without using additional anti-seizure medication. Termination of SE is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic SE after 15 minutes in those with EEG monitoring and no improvement in consciousness.

Secondary objectives include determining the relative safety of the treatment arms on defined safety outcomes and all adverse events, analysis of secondary/exploratory efficacy outcomes, and evaluation of both effectiveness and safety in the pediatric subpopulation.

The trial will initially allocate subjects equally (1:1:1) for the first 350 participants (burn-in period) before transitioning to response-adaptive randomization. Interim analyses will be conducted for efficacy and futility beginning when 350 subjects have been randomized, and will occur every 100 subjects thereafter. A maximum of 770 participants will be enrolled.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Status Epilepticus, Status Seizure
  • Age: 1 years or above
  • Gender: All

Inclusion Criteria:

  • The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
  • The patient received an adequate dose of benzodiazepines. The doses may be divided.
  • The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
  • Continued or recurring seizures in the Emergency Department.
  • Age 1 years or older
  • Known or estimated weight ≥10 Kg

Exclusion Criteria:

  • Known pregnancy
  • Prisoner
  • Opt-out identification or otherwise known to be previously enrolled in KESETT
  • Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
  • Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
  • Endotracheal intubation prior to enrollment
  • Acute traumatic brain injury clearly precedes seizures
  • Scalp injury or burn preventing EEG placement
  • Known allergy or other known contraindication to KET or LEV
  • Hypoglycemia < 50 mg/dL
  • Hyperglycemia > 400 mg/dL
  • Cardiac arrest / post-anoxic seizures

This study investigates the effectiveness of adding an investigational medication to an existing treatment for status epilepticus, a serious condition where seizures do not stop. Status epilepticus is when a person has a seizure that lasts too long or has many seizures close together without recovering in between. The purpose of this study is to see if giving two doses of an investigational medication with levetiracetam is better at stopping these seizures than giving levetiracetam alone.

Participants in the study will be randomly assigned to one of two study arms. One group will receive levetiracetam alone, while the other group will receive levetiracetam plus the investigational medication. Doctors will monitor the participants closely to see if the seizures stop and if there are any side effects. The study will also look at how safe the treatments are for children.

  • Who can participate: Participants must be 1 year or older, have a convulsive seizure lasting more than 5 minutes, and have received benzodiazepines 5-30 minutes before the study drug. They must weigh at least 10 kg and be treated in the Emergency Department for ongoing seizures.
  • Study details: Participants will receive either levetiracetam alone or levetiracetam plus an investigational medication. Doctors will monitor the participants to see if the seizures stop, check for any side effects, and monitor consciousness and EEG as part of the study procedures.
Updated on 06 Jul 2026. Study ID: EMER-SIREN-KESETT, 28345
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only